The FDA will use this feedback to consider improvements to the website in order to make the information as user-friendly as possible
In the first phase of this pilot website, only one trial will be included while the FDA seeks public feedback on how the information is presented. The FDA will use this feedback to consider improvements to the website in order to make the information as user-friendly as possible.
The visualisations and data included on the website are voluntarily provided by the drug companies that conducted the clinical trials. AstraZeneca is the first company to provide patient-reported outcome data for one of their FDA-approved drugs and has collaborated with the FDA to identify methods to display the information in a way that is informative to healthcare professionals and patients.
“There have long been calls to provide information to patients about how they may feel and function when receiving cancer treatment. By initiating Project Patient Voice, we are moving towards standardized methods to display these outcomes, starting with patient-reported symptomatic adverse events,” said Paul Kluetz, MD, Deputy Director of the FDA’s OCE. “We encourage sponsors to collect this data systematically and look forward to welcoming additional sponsor collaboration as we work to help further serve the patient community.”
Project Patient Voice is not meant to replace the clinician-reported safety information that is available as part of a drug’s labelling. Data from Project Patient Voice should not substitute for advice from a health care professional. Rather, Project Patient Voice serves as a complement to FDA patient labelling and patient information, not a sole source of information on which to make decisions about medical care.
The FDA will seek public feedback regarding the Project Patient Voice pilot effort at a virtual public workshop co-sponsored with the American Society of Clinical Oncology on July 17. The “Clinical Outcome Assessments in Cancer Clinical Trials” workshop will include healthcare providers, patients, health outcomes researchers, industry, advocacy groups and other stakeholders interested in the rigorous measurement of symptom and functional outcomes. In addition to discussing trial design considerations to obtain patient-reported symptomatic side effects, the FDA will obtain feedback on the presentation of PRO symptomatic side effect data on the Project Patient Voice website to further ensure that the information is clear and meaningful to health care professionals and patients.